BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPIRA RX PTCA DILATATION CATHETER

    MDR report key: 2782890 · Received October 3, 2012

    Report

    Report Number
    3008950987-2012-00007
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS WERE REVIEWED AND THERE IS NO OBJECTIVE EVIDENCE TO SUGGEST THAT THE DEVICE MAY HAVE BEEN RELEASED WITH NON-CONFORMITIES RELATED TO THE NATURE OF THIS COMPLAINT. THE DEVICE MET SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    FRACTURED EMPIRA BALLOON OCCURRED DURING A PCI. (NO PT INFO PROVIDED AT THIS TIME).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPIRA RX PTCA DILATATION CATHETER LOX, CATHETERS PTCA LOX CREGANNA-TACTX MEDICAL 85R20200S CE0000766

    Patients

    Seq Age Sex Outcome Treatment
    1